Quality Control Raw Material Analyst (Biotech)

Location: On-site in Bridgewater, New Jersey, United States

Company

hirify.global operates a Smart Factory supporting cGMP manufacturing operations.

What you will do

• Perform incoming inspection, sampling, and quarantine handling for raw materials, components, and single-use systems.
• Verify supplier documentation, including CoAs and CoCs, against purchase orders, specifications, and supplier qualification records.
• Coordinate sample shipments to external contract testing organizations and internal laboratories, maintaining packaging, temperature, regulatory, and chain-of-custody requirements.
• Perform compendial and physicochemical testing, including pH, osmolality, conductivity, visual inspection, and FTIR.
• Review test results and peer verification data to support material disposition in ERP/QMS systems.
• Investigate OOS/OOT results, deviations, and CAPAs, and support change controls, audits, inspections, SOP updates, training, and quality metrics reporting.

Requirements

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline; comparable experience may be considered.
• 2+ years of hands-on experience in a cGMP pharmaceutical, biotech, or CDMO/IDMO environment, preferably in raw material or incoming quality control.
• Working knowledge of USP compendial methods and familiarity with USP, EP, ICH Q3C, and ICH Q3D standards.
• Experience with AQL-based sampling, statistical sampling, sample shipment coordination, cold-chain logistics, and external testing laboratories is preferred.
• Proficiency with electronic QMS, ERP, or LIMS systems such as TrackWise, SAP, or LabVantage.
• Must be able to commute to and work on-site in Bridgewater, New Jersey.

Nice to have

• Experience with AQL-based sampling plans and statistical sampling methodologies.
• Experience coordinating shipments to external contract testing organizations.
• Familiarity with raw material qualification frameworks and cold-chain logistics.

Culture & Benefits

• Fast-paced, mission-driven working environment.
• Opportunities to support a growing organization and contribute to quality systems.
• Hands-on training and qualification of new associates in sampling and testing procedures.
• Required GMP training and participation in audit-ready quality practices.

Hiring process

• Leveling is based on overall experience, education, and demonstrated knowledge throughout the interview process.